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CompletedNCT05752864Updated Dec 27, 2023

The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea

An interventional study of spine manual therapy and Superficial heat therapy in Primary Dysmenorrhea, sponsored by Sahmyook University. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Sahmyook University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 29 Years
Sex
Female
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Study summary

Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves.

The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea.

In this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.

02

Conditions studied

  • Primary Dysmenorrhea
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In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Sahmyook University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 29 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women between the ages of 20-29
  • Regular menstrual cycle (24-32 days)
  • Those who have had symptoms of primary dysmenorrhea for at least 1 year
  • Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
  • The body mass index is between 20-30
  • Positive reaction to Gillet test

Exclusion criteria

Exclusion Criteria:

  • pelvic inflammatory disease
  • uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
  • Those who have used an intrauterine contraceptive device
  • Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    spine manual therapy of sacroiliac joint

    The group which treats spine manual therapy of sacroiliac joint

    Behavioral: spine manual therapy

  • Active comparator
    Superficial heat therapy

    Group treated with superficial heat therapy for 20 minutes

    Device: Superficial heat therapy

Interventions

  • Behavioralspine manual therapy

    The manual treatment method applied to the sacroiliac joint used high-velocity, low amplitude (HVLA).

  • DeviceSuperficial heat therapy

    In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.

06

What researchers measure

Primary outcomes

  1. Heart Rate Variability

    Autonomic nervous system balance tester (SA3000new, Medicore Co. Korea) was used. The subjects placed electrodes on three areas (left arm, left leg, right leg) while lying down and performed for 3 minutes.

    Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

Secondary outcomes

  1. Visual analog scale

    On a line consisting of 10 cm, 0 at either end represents 'no pain' and 10 represents 'worst pain'.

    Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

  2. Pressure pain threshold

    The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. With the participant seated comfortably, the examiner identified the sacroiliac joint and applied pressure with the algometer perpendicular to the skin surface until the participant made an "Ah" sound. * Lower pressure pain thresholds indicate higher sensitivity to pressure and a lower pain tolerance. * Higher pressure pain thresholds suggest lower sensitivity and a higher pain tolerance.

    Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

  3. Menstrual distress questionnaire

    The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical menstrual cycle symptoms. The MDQ can differentiate between cyclical and non-cyclical changes in somatic symptoms, mood and behavior, and arousal. -The measured scores range from 0 to 185; higher scores indicate severe dysmenorrhea symptoms.

    Time frame: Change from baseline after intervention at 4 weeks, follow-up at 4 weeks

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Study locations

1 site
  • The wells neuropain clinic
    Seoul, 05557, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05752864
Lead sponsor
Sahmyook University
Responsible party
Hyun-Joong Kim (Doctor, Sahmyook University) — Principal investigator
First posted
Mar 3, 2023
Start date
Apr 30, 2023
Primary completion
Jun 30, 2023
Completion
Aug 30, 2023
Last update
Dec 27, 2023

Study contacts

Sungeon Park, Ph.D candidate
principal investigator · The wells neuropain clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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